Mitigating radiation dermatitis in breast cancer patients through early skin preparation:
A clinical trial of an atelocollagen complex-based intervention - key summary
Despoina Kokkinidou 1 , Constantina Cloconi 2 , Antria Savva 2 , Christina Georgiou 2 , Maria Kyprianidou 3 , Eleftheria Sidira 1 , Anna Christofini 1 , Konstantinos Ferentinos 2 , Angelos Kassianos 3 , Constantinos Zamboglou 2 , Marianna Prokopi-Demetriades 1
1 RSL Revolutionary Labs Ltd, Limassol, Cyprus,
2 German Medical Institute, Limassol, Cyprus,
3 Cyprus University of Technology, Limassol, Cyprus
METHODS
A randomized, double-blind, controlled clinical trial was conducted at the German Medical Institute in Cyprus, involving 80 breast cancer patients undergoing radiotherapy. Participants were randomized into two groups: an intervention group using the atelocollagen-based cream (ATC; 0.1% triple atelocollagen complex-based cream) and a control group receiving standard of care (SOC; 2% panthenol-based cream).
The product was administered beginning one day prior to the initiation of radiation therapy and continued throughout the treatment period, and radiation dermatitis severity was evaluated weekly during the radiotherapy session and at two post-treatment follow-ups (1-week and 1-month post-radiation treatment) using CTCAE guidelines assessment and photography documentation.
Over 90 % full recovery 1 month post-therapy with ATC cream vs < 50 % with SOC
**** p < 0.0001
At one-month post-therapy, over 93% of patients in the intervention group achieved full recovery, compared to less than 50% in the control group. Grade II radiodermatitis was effectively prevented in the intervention group and reductions in skin or nipple-areolar hyperpigmentation were observed, with the intervention group reporting less severe side effects at all timepoints.
Higher psychosocial well-being and comfort scores only in the ATC group
Significant improvement in psychosocial health and symptom management.
Psychosocial Health, where results indicate an increase in overall psychosocial well-being only in the ATC group, while the SOC group showed a decline.
SUMMARY OF RESULTS
At 1-month post-treatment
- Over 90% full recovery 1-month post-therapy with the ATC cream versus less than 50% with SOC.
- Less severe side effects with the ATC cream at all time points.
- The protective effect of ATC became more evident over time, with a greater proportion of patients exhibiting lower radiodermatitis grades.
- A substantial proportion of the SOC (50%) continued to exhibit Grade I radiodermatitis.
- The incidence of Grade II radiodermatitis was minimal in the ATC group, while it persisted in the SOC.
- The differences between the groups remained highly statistically significant.
CONCLUSION
Early application of the atelocollagen complex-based dermaceutical cream significantly reduced radiation dermatitis severity and enhanced recovery compared to standard care.
These findings highlight its potential as an effective protective intervention. Further validation through larger-scale clinical trials is warranted to confirm its efficacy and long-term benefits.
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